Genentech Bars Compounding Pharmacies from Bevacizumab
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Genentech Bars Compounding Pharmacies from Bevacizumab
IS THE OFF-LABEL USE OF AVASTIN FOR THE TREATMENT OF AMD IN JEOPARDY?
■ As of Jan. 1, bevacizumab (Avastin) manufacturer Genentech will no longer permit wholesale distributors to sell the drug directly to compounding pharmacies, which repackage it in smaller doses for ocular injection.
The reason for the decision
Genentech's decision was due in part to the Food and Drug Administration's (FDA) concern over the sterility and repackaging of the drug for ocular use, wrote Susan Desmond-Hellmann, M.D., M.P.H., the company's president of Product Development, in a "Letter to Physicians," posted on Genentech's Web site (www.gene.com) in October.
Specifically, she wrote that a compounding pharmacy received a warning letter from the FDA, which raised concerns over the sterility of the repackaged drug. In addition, Genentech destroyed four batches of the drug at its South San Francisco manufacturing facility because an FDA visual inspection deemed them unsuitable for eye use, wrote the president. She also noted that bevacizumab hasn't undergone any formal, randomized, controlled clinical trials for ocular use.
Genentech also manufactures ranizumab (Lucentis), which is FDA approved for AMD. Bevacizumab, however, has been the drug of choice for many ophthalmologists due to its efficacy, which is similar to that of ranizumab, and its lower price tag (approximately $50 to $100 per injection, vs. ranizumab's $2,000 per injection).
"…We must stay up to date on this, so we can answer our patient's questions and allay their fears…," says Rex Ballinger, O.D., a member of the Optometric Retina Society. "Patients will greatly appreciate being better informed on treatment methods and options prior to their retinal specialists visit."
Prevent Blindness PSA
Prevent Blindness America has announced the launch of a national consumer eyecare awareness campaign, set to begin this month (December). The campaign, made possible by an educational grant from Pfizer, includes television, print and radio public service announcements (PSA) that highlight the importance of preventive eye care.
"We decided to launch this campaign in response to the growing population of aging adults, who are susceptible to eye diseases, such as age-related macular degeneration, that cause blindness," says Daniel Garrett, vice president of Prevent Blindness America. "We want to ensure that both older adults and their caregivers are more mindful of the fact that half of all blindness is preventable just through a simple eye exam."
Prevent Blindness America has distributed the PSAs to 800 television stations and cable networks, 1,500 radio stations and 100 Web sites, such as Lifetime www.mylifetime.com.
FDA Approves Glaucoma Drop
COMBINATION DRUG COMBINES TWO KNOWN GLAUCOMA MEDICATIONS
■ The FDA has approved brimonidine tartrate/timolol maleate 0.2%/0.5% (Combigan, Allergan) prescription drop for glaucoma or ocular hypertensive patients. The drop is an alpha-adrenergic receptor agonist with a beta-adrenergic receptor inhibitor that lowers elevated intraocular pressure (IOP) in patients who need adjunctive or replacement therapy as a result of insufficient IOP control.
Brimonidine tartrate/timolol maleate lowers IOP via b.i.d. dosing by reducing aqueous humor production and enhancing aqueous humor drainage via the uveoscleral pathway, according to Allergan.
The drug is contraindicated in patients who have either a history of or current bronchial asthma; severe chronic obstructive pulmonary disease; sinus bradycardia; second- or third-degree atrioventricular block; overt cardiac failure; cardiogenic shock and hypersensitivity to any component of the drug, the company says.
Drivers See Challenges in Driving in Low-Light Conditions
NEW RESEARCH ON NIGHT DRIVING
■ According to a recent survey, 32% of drivers said they have difficulty seeing while driving in the dark, and 23% said they lack confidence about their driving skills in the dark. In addition, 24% of respondents said that vision problems and discomfort left them feeling concerned about driving, and 21% said these issues left them feeling unsafe while driving. In total, 67% report difficulty driving in the dark at least some of the time.
These are the some of the findings of "Shedding Light While Driving in the Dark," a nationwide survey of 515 vision-corrected Americans ages 18 and older. The survey, conducted by Kelton Research on behalf of Road & Travel Magazine and Acuvue brand contact lenses (Vistakon), aimed to assess attitudes, perceptions, practices and experiences of driving in low-light conditions. ("Low-light conditions" refers to night or early morning driving.)
The survey identified a number of hazards of driving in low-light conditions. For example, 53% of the participants said their vision problems usually make them feel uncomfortable while driving in the dark.
As might be expected, glare or light sensitivity affected a large portion (48% of the participants), while 61% reported having been bothered by headlights. In addition, 28% reported seeing halos or starburst patterns around lights.
About one-fifth of the participants said they experienced blurred distance vision while driving in low light, and 5% say they have difficulty in seeing the dashboard or dials.
One-fifth of the respondents also said they had trouble seeing animals and pedestrians while driving in the dark, while 26% said they experienced difficulty in seeing signs or exits. A total of 22% said they had difficulty in judging distances.
According to the study, vision problems make women feel more uncomfortable than men (27% vs. 17%), less safe than men (25% vs. 17%) and more anxious while driving (25% vs. 16%).
The study also uncovers an opportunity for optometrists and their patients: A total of 73% of the respondents report that they believe correcting their vision problem could improve their driving at night, yet only 27% have ever consulted with an eyecare professional about treatment or products that could improve their vision. Optometrists can literally show patients the light with a new pair of glasses or contact lenses.
Study Extols the Benefits of High Dk/t Contact Lenses
A NEW APPROACH TO OXYGENATION
■ The higher a contact lens' DK/t, the closer the lens comes to meeting the cornea's oxygen needs, according to a study in July's Cornea.
The study, conducted by a research team from CIBA Vision (Alvord et al), used finite element analysis (FEA), a new method of predicting corneal oxygenation during lens wear. FEA models a contact lens on the eye in two dimensions and provides a three-dimensional analysis of the contact lens on the corneal surface, from the center of the lens to the periphery and from the pre-lens tear film to the endothelium of the cornea.
The study found that the differences in Dk/t in contact lenses affect overall corneal oxygenation, as reflected in the amount of oxygen that permeates the lens to reach the cornea. The study showed that it's more challenging to supply oxygen to the peripheral cornea than to the central cornea. So, the researchers say, one cannot base the minimum contactlens Dk/t required to adequately oxygenate the cornea on analysis that considers only the lens center. The study confirmed that oxygen diffusion from the vascular bed at the cornea/sclera junction doesn't play a major role in corneal oxygenation.
The study also indicates that contact-lens wearers can benefit from new materials, those "with even higher Dk/t than are currently available," says Dr. Lynn Winterton, CIBA Vision global head of research.
Chairman of the Board Appointment
Richard S. Kattouf, O.D., was elected as the chairman of the Board of Trustees at the Illinois College of Optometry (I.C.O.). Dr. Kattouf (pictured on the right) is accompanied by Mrs. Valerie Kattouf and Dr. Arol Augsburger, president of I.C.O. Dr. Kattouf, the practice management editor of Optometric Management, is founder and president of Kattouf Consulting Services and founder of Heye Tech, a national training program on DVD for ophthalmic assistants.
|● Type-2 diabetes mellitus patients who took fenofibrate, a drug that reduces types of fat in the blood, for five years decreased their need for diabetic retinopathy laser treatment. The mechanism of action, however, doesn't appear to be related to plasma concentrations of lipids, says a study published in the November 17 issue of The Lancet.|
● The FDA has approved the Acuvue Oasys brand contact lens with Hydraclear Plus for therapeutic use as a bandage lens for certain acute and chronic ocular conditions. The lens can also provide vision correction during healing, if required.
● Loteprednol etabonate (Lotemax, Bausch & Lomb) with topical cyclosporine 0.05% (Restasis, Allergan) provides more rapid relief of dry-eye signs and symptoms with greater efficacy than Restasis and tears alone, according to a study of 118 patients (American Academy of Ophthalmology poster "Prospective, Multicenter, Randomized Controlled Study on the Effect of Loteprednol Etabonate on Initiating Therapy with Cyclosporine A," Donnenfeld, E.D., et al). Loteprednol etabonate also reduced the stinging associated with Restasis and improved compliance.
● Using CMC-solutes (Optive, Allergan) adjunctively with topical cyclosporine 0.05% (Restasis, Allergan) for the treatment of dry eye improved Ocular Surface Disease Index scores at month one, and improved tear break-up time scores and conjunctival lissamine-green staining scores at month three, says a report on 19 patients in Current Medical Research and Opinion.
● Implementation of the International Task Force guidelines for diagnosis and treatment of dry-eye disease was simple and not time consuming, says a study in the April issue of Cornea. Nine physicians and 183 patients participated in the study.
|□ Teamwork Marketing, an ophthalmic industry consulting firm, announced it offers low-vision business development services for private-practice optometrists. For more information call (909) 484-9539, or visit www.teamwork-marketing.com.|
□ Bausch & Lomb named A. Robert D. Bailey corporate vice president and general counsel. Bailey, 44, was most recently vice president, assistant general counsel and assistant secretary for the company. He replaces Robert B. Stiles, who has announced his intention to retire from Bausch & Lomb in 2008.
□ SynergEyes, the contact-lens manufacturer, was recognized as one of the year's best technology companies by the San Diego chapter of the American Electronics Association (AEA), a high-tech industry association.
□ The Vision Council of America (VCA) has formed the Vision Protection Committee to address the vision-protection market, including sports, industrial safety, computer vision and home and sun protection. For more information, contact Tom Goeltz, VCA Vision Protection Committee consultant at email@example.com.
□ VSP Vision Care has received the World Class Customer Satisfaction Award from Service Quality Measurement Group. VSP was judged using a sample size of 8,700 customer telephone surveys taken from a random selection of calls. A call center must score 80% or better in the very satisfied category to achieve a worldclass rating.
□ Illinois College of Optometry's Yi Pang, Ph.D., O.D., F.A.A.O., assistant professor of optometry, and Dominick M. Maino, O.D., M.Ed., F.A.A.O., F.C.O.V.D.-A, professor of pediatrics and binocular vision, have won the Optometry & Vision Development 2006 Best Article Award for their paper on controlling myopia.
□ The American Medical Association will issue CPT code 87809, that will cover the Rapid Pathogen Screening Adeno Detector, effective January 1, 2008.
Academy Publicizes Research and Ophthalmic Products
A REVIEW OF THE AAO ANNUAL PRESS CONFERENCE HELD DURING THE ANNUAL MEETING IN TAMPA
■ The American Academy of Optometry (AAO) press conference, held recently at the AAO annual meeting in Tampa, Fla. presented a number of scientific papers as well as a sampling of the latest ophthalmic products. The following report provides an overview of the press conference.
► Evaluation of the clinical effects of lens age during silicone hydrogel lens wear
Daniel Tilia, B.Optom., M.Optom., of the Vision Cooperative Research Centre, urged practitioners to be diligent in advising patients to replace contact lenses. In a study of 575 subjects, patients found increased comfort with older lenses, even though the lenses showed corresponding increases in surface deposits and mucin balls.
► Corneal reshaping and yearly observation of nearsightedness (CRAYON) study
Corneal reshaping contact lenses slow the axial growth of the eye, and the treatment effects continue to accumulate over two years, concluded research of eight- to 11-year old children presented by Jeffrey A. Walline, O.D., Ph.D., of Ohio State University.
► Visual activities and progression of juvenile-onset myopia
Karla Zadnik, O.D., Ph.D., of Ohio State University, reported that in a study of 640 children, associations between either weekly sports/outdoor activities or reading hours and annual myopic progression are statistically significant, but they are neither robust across different measures of the sports and reading variables or clinically significant in terms of their magnitude.
► Metrics of retinal image visual quality cannot account for decreased visual acuity with increasing age for physiologic pupils.
Raymond A. Applegate, O.D., Ph.D., presented research that concluded that acuity loss with increasing age in the normal aging eye under physiological pupils is unlikely due to increases in optical aberrations with age, and is likely due to neural changes combined with other optical effects, including scatter and decreased-light transmission.
► Compliance with current contact-lens care regimens
In a study of 80 contact-lens wearers, Kathryn A. Dumbleton, O.D., of the Centre for Contact Lens Research, concluded that compliance with instructions for "no rub" contact-lens solutions was poor and significantly worse than compliance for a hydrogen-peroxide solution. In addition, patients don't treat their lens cases appropriately, she found.
► VA low-vision intervention trial (LOVIT)
Robert Massof, O.D., Ph.D., of the Wilmer Eye Institute, reported on research which concluded that an increase in the maximum reading rate was observed in low-vision patients following rehabilitation, most likely the result of eccentric viewing training.
► Accommodative lag is not related to myopia progression
Research presented by David A. Berntsen, O.D., of Ohio State University, concluded that accommodative lag was not significantly associated with myopia progression. The data suggest that greater amounts of hyperopic retinal blur due to near activities don't drive juvenile-onset myopia progression.
► Myobloc-induced paresis of accommodation
Sara J. Huffman, O.D., of the University of Houston, reported that while paresis of accommodation as a side effect of botulinum toxin A (Botox, Allergan) has rarely been noted, eyecare providers should remain aware, as the use of the cosmetic drug expands.
► Functional vision analyzer
The Functional Vision Analyzer (Stereo Optical) combines a number of vision tests, including contrast sensitivity tests using sine (sign?) wave gratings under variable conditions to evaluate functional vision. The system's software then generates a pictorial model of the patient's functional vision under day and night conditions, both with and without glare.
► Perimeter uses new "flicker defined form" technology
The Heidelberg Edge Perimeter (HEP, Heidelberg) is a new technology that uses a stimulus called Flicker Defined Form, which targets M-cells, and has been shown to be highly sensitive to functional loss due to early glaucoma. According to the company, the test is more comfortable to patients and results in higher test-retest reliability than conventional methods.
► Contact lens designs for challenging fits
The Proclear Multifocal Toric and the Proclear 1-Day Contact Lens (Coopervision) were developed to address specific challenges. The Multifocal Toric, made with PC Hydrogel material is the only available monthly disposable toric. The 1-Day lens is not new, but was presented due to renewed interest in addressing patient compliance, lens/solution incompatibility and incidences of microbial contamination.
► Eye drops and vitamin
Bausch & Lomb presented its line of eye drops, including Soothe XP emollient drops, which provide dryeye relief and restore the lipid layer of the tear film, and Soothe Lubricant Eye Drops, which are preservative free. The company also presented Ocuvite DF eye vitamin supplement, specifically developed for diabetics to help maintain eye health.
► Intraocular lens (IOL)
Alcon presented the AcrySof Restor IOL, the only Food & Drug Administration-approved presbyopia-correcting IOL that incorporates aspheric optics into its design.
► Software for computer users who have low vision
MAGic screen magnification software (Freedom Scientific) enables low-vision patients who use computers to magnify text and other visual elements that appear on screen. The software includes a low-vision speech option in which users hear text spoken as they drag the cursor across the text. The software can also read entire documents or magnify screen information up to 36 times.
► Retinal imaging operating software
V2 software (Optos) offers several advances in diagnosis and patient education for users of the Optomap retinal imaging device. These include: 3D Wrap patient orientation tool, high resolution enhancement for central pole, practice performance statistics and targeted ophthalmoscopy mode.
► "Pinkeye" therapy reduces dosing regimen
Inspire Pharmaceuticals launched azithromycin ophthalmic solution 1% (AzaSite) for the treatment of bacterial conjunctivitis. The recommended dose is b.i.d. for two days, followed by q.d. for the next five days, for a total of nine drops, vs. 21 drops (t.i.d. dosing for seven days) for competing drops.
► Lubricating drops
Optive lubricating eye drops (Allergan) relieve the symptoms of dry eye in two ways, says the manufacturer. The drop provides a lubricating and hydrating protective shield on the surface of the eye. And also penetrates below the surface to provide protection to the corneal epithelial cells from excessive salt levels.
Optometric Management, Issue: December 2007